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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE Back to Search Results
Model Number 625-0T-28D
Device Problem Material Erosion (1214)
Patient Problems Foreign Body Reaction (1868); Osteolysis (2377)
Event Date 11/05/2021
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Tha was performed on (b)(6) 2008 (j543-11-46d, 625-0t-28d).Revision was performed on (b)(6) 2021 due to metallosis.There was osteolysis around the acetabulum and proximal stem and it was treated with vancomycin and bone graft.The liner and head were replaced.The back of the liner showed metal wear debris.The doctor would like to know which part of the liner is worn and how much.Originally, is there any marking or unevenness on the tapered edge of the liner? surgeon said that there may have been something on it, but it disappeared due to wear.
 
Manufacturer Narrative
Reported event: an event regarding wear (metallosis) and osteolysis involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device had scratches/nicks on the metal and ceramic surfaces.Damage is consistent with attempted implantation/explantation.No wear was observed on the device.No further surface discrepancies were observed.Material analysis: damage observed on the liner is consistent with attempted implantation/explantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: it was reported that the patient was revised due to reported wear (metallosis) and osteolysis.Visual inspection of the returned device indicated that no wear was observed on the surface of the device.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
Tha was performed on (b)(6) 2008 (j543-11-46d, 625-0t-28d).Revision was performed on (b)(6) 2021 due to metallosis.There was osteolysis around the acetabulum and proximal stem and it was treated with vancomycin and bone graft.The liner and head were replaced.The back of the liner showed metal wear debris.The doctor would like to know which part of the liner is worn and how much.Originally, is there any marking or unevenness on the tapered edge of the liner? surgeon said that there may have been something on it, but it disappeared due to wear.
 
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Brand Name
TRIDENT ALUMINA INSERT
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
EI   NA
Manufacturer Contact
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12891214
MDR Text Key281395598
Report Number0002249697-2021-01982
Device Sequence Number1
Product Code MRA
UDI-Device Identifier04546540516831
UDI-Public04546540516831
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P000013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2012
Device Model Number625-0T-28D
Device Catalogue Number625-0T-28D
Device Lot Number24474402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexFemale
Patient Weight50 KG
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